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Vascutek Cardiovascular Fabric is indicated for vascular repair whenever knitted polyester fabrics are normally indicated.

Due to its particularly high strength. Gelseal is especially suitable for thoracic use whereas the softer handle of the Gelsoft makes it ideal for peripheral use. The Thin Wall fabric is designed for endaterectorny, particularly of the carotid arteries.

The Vascutek Cardiovascular Fabric are a range of gelatin sealed, knitted, polyester patch fabrics. The range consists of three different patch fabrics which are manufactured using identical materials, processes and procedures but which, because of slight differences in the pattern of the base fabric, exhibit different physical characteristics. This range of products is provided in order to give the implanting surgeon a choice of several different fabrics from which they can chose the most suitable according to their own preferences and according to specific demands of any given surgical situation.

Two of the patches, Gelseal™ and Gelsoft™, are based on fabrics which are currently used in Vascutek's range of tubular vascular prostheses, which have received Premarket approval from the FDA. The only difference between the cardiovascular fabrics and the tubular grafts is that the patches are produced in flat, patch formats (i.e. square or rectangular) and have not been subjected to the crimping process which is used in the production of the tubular prostheses. With this single exception, the manufacturing facilities, equipment, processes and the quality control processes and procedures are identical to those used in the manufacture of the Gelseal™ and Gelsoft™ vascular prostheses.

The third type of patch, the Thin Wall Carotid Patch, is also manufactured using the identical materials, processes and procedures as the other cardiovascular patches but with a slightly modified knit pattern. This new structure has been developed in order to maintain the physical characteristics necessary for general cardiovascular patching but with a reduced wall thickness and characteristics which make it ideally suited to use for parching carotid arteries after endarterectomy procedures.

This is a 510(k) premarket notification for a medical device, not a study evaluating an AI algorithm. Therefore, the requested information about acceptance criteria, study design, expert involvement, and ground truth for an AI device is not available in the provided text.

The document describes the Vascutek Gelseal Patch, Vascutek Gelsoft Patch, and Vascutek Thin Wall Carotid Patch, which are cardiovascular fabric patches. The FDA has determined these devices are substantially equivalent to legally marketed predicate devices.

The "study" referenced in the document is a series of nonclinical tests performed to demonstrate that the device is safe and effective when compared to predicate devices. These tests included:

• Physical testing
• Biocompatibility testing
• Chemical characterization
• An animal performance study

The purpose of these tests was to show that the new devices, with a change in the gelatin supplier, perform as well as the previously approved devices.

Since this is not an AI device, the specific questions about acceptance criteria related to AI performance metrics (like sensitivity, specificity, or AUC), sample sizes for AI training/test sets, expert adjudication, or MRMC comparative effectiveness studies are not applicable and therefore cannot be answered from the provided text.

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Vascutek Cardiovascular Fabric is indicated for vascular patch grafting and for intracardiac patching. The Thin Wall Carotid Patch is, in addition, indicated for patch closure after endarterectomy, particularly of the carotid arteries.

The Vascutek Cardiovascular Fabric product line consists of a non-crimped Gelseal™ patch, Gelsoft™ patch, and a Thin Wall Carotid patch. Each patch product line is gelatin-sealed, knitted polyester, with a base fabric porosity of 1460 ml/min/cm2, 2118 ml/min/cm2 and 3515 ml/min/cm² respectively, and are available in various square or rectangular sizes. The polyester fabrics have been impregnated with an absorbable mammalian gelatin which seals the prostheses in the same manner as the fibrin deposited in traditional preclotting procedures. The gelatin sealant obviates the need for preclotting prior to implantation. The gelatin is of United States Pharmacopeia (USP) standard and is derived from bovine bone.

Here's an analysis of the provided text regarding the Vascutek Cardiovascular Fabric, focusing on acceptance criteria and study details.

Based solely on the provided text, it's clear that this document describes a traditional medical device submission (likely a 510(k)) and not an AI/ML powered device. Therefore, many of the requested fields related to AI/ML specific studies (like sample sizes for test/training sets, expert adjudication, MRMC studies, standalone algorithm performance) are not applicable to this product.

The acceptance criteria here are for mechanical and material performance, and the "study" is a comparison to a predicate device through in-vitro and previously accepted in-vivo testing.

1. Table of Acceptance Criteria and Reported Device Performance

Notes on Acceptance Criteria:

• The primary acceptance criterion is "substantial equivalence" to the predicate device for in-vitro performance (burst strength, suture retention, tensile strength, water porosity). This means performance must be comparable to, and not worse than, the predicate for safety and effectiveness.
• For material composition and established components (like the gelatin sealant), the criterion is often meeting recognized standards (USP) or prior regulatory approval (PMA).

Study Information (as it pertains to this non-AI/ML device):

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

   • Test Set Sample Size: Not specified in terms of number of physical units tested beyond "Comprehensive in-vitro performance testing" and "previously accepted animal testing." Testing would typically involve multiple samples per test (e.g., n=5 or n=10 per test for burst strength).
   • Data Provenance:
     • Country of Origin: Not specified for the in-vitro performance tests. The company location is Austin, Texas, USA.
     • Retrospective or Prospective: The in-vitro testing would be prospective (conducted specifically for this submission). The "previously accepted animal testing" is retrospective in relation to this submission but was prospective during its original conduct.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

   • Not Applicable. This is a physical medical device. "Ground truth" is established by direct physical measurements according to validated test methods and comparison to a predicate device, not by expert interpretation of data.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

   • Not Applicable. Adjudication methods are relevant for subjective interpretations, often in image analysis. Here, performance is measured objectively.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

   • Not Applicable. This is not an AI/ML device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

   • Not Applicable. This is not an AI/ML device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

   • For in-vitro performance: The "ground truth" is established by the objective, quantitative measurements obtained from validated mechanical and material tests (e.g., direct measurement of burst pressure, tensile strength, water porosity). The comparator "ground truth" is the performance of the predicate device.
   • For biocompatibility/safety of gelatin: The "ground truth" is previous regulatory approval (PMA# P890045) and adherence to established standards (USP).
   • For in-vivo performance: The "ground truth" was derived from animal testing outcomes, which were previously deemed acceptable.

8. The sample size for the training set

   • Not Applicable. This is not an AI/ML device.

9. How the ground truth for the training set was established

   • Not Applicable. This is not an AI/ML device.

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